Medical emergency?Emergency? Call 911. Nearest emergency roomsNearest ERs

Español Near me My list Help
US Patient GuideUSA
Surprise me
Prescription medicine · generic available

Naproxen

Brand names: Naprelan, Rugby All Day Relief

Also listed by the FDA as: naproxen · naproxen sodium

Also sold without a prescription: Naproxen (over the counter) →

Drug class: Nonsteroidal Anti-inflammatory Drug

The FDA’s “Established Pharmacologic Class”: the group of medicines that work in a similar way.

Full FDA label All drugs

Official FDA data, not advice

Everything here comes from the U.S. Food and Drug Administration (FDA): the drug label, the NDC Directory, Drugs@FDA, recall reports and the drug shortage list. Each fact shows its source and date.

This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or change any medicine.

In an emergency, call 911. If someone may have taken too much of a medicine, call Poison Help: 1‑800‑222‑1222.

At a glance

YesBoxed warning
None listedFDA shortage list
6Recalls (FDA reports)
55Companies
1987First FDA approval on file

Quick answers

What is Naproxen used for?
The FDA-approved label (Naprelan, Upsher-Smith Laboratories, LLC, January 8, 2026) says: “NAPRELAN Tablets are indicated for the treatment of: • rheumatoid arthritis (RA) • osteoarthritis (OA) • ankylosing spondylitis (AS) • tendinitis, bursitis • acute gout • primary dysmenorrhea (PD) • the relief of mild to moderate pain […]. NAPRELAN is a nonsteroidal anti-inflammatory drug indicated for the treatment of …” This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or change any medicine.
Does Naproxen have a boxed warning?
Yes. The FDA label for Naprelan has a boxed warning (“WARNING: RISK OF SERIOUS CARDIOVASCULAR AND GASTROINTESTINAL EVENTS”), the FDA’s strongest warning. Read it on the full label and ask your pharmacist.
Is there a shortage of Naproxen?
No current shortage is listed by the FDA for the products of this medicine (FDA data from October 30, 2026).
Has Naproxen been recalled?
FDA enforcement reports list 6 recalls of products of this medicine; the newest started April 20, 2026 (Class II). A recall usually concerns specific lots, not every product.
Who makes Naproxen?
55 companies list prescription products of Naproxen in the FDA NDC Directory, including Bryant Ranch Prepack, A-S Medication Solutions and Proficient Rx LP.

What Naproxen is used for

Quoted from the “Indications and Usage” section of the FDA-approved label.

NAPRELAN Tablets are indicated for the treatment of: • rheumatoid arthritis (RA) • osteoarthritis (OA) • ankylosing spondylitis (AS) • tendinitis, bursitis • acute gout • primary dysmenorrhea (PD) • the relief of mild to moderate pain […]. NAPRELAN is a nonsteroidal anti-inflammatory drug indicated for the treatment of …

— FDA label: Naprelan, Upsher-Smith Laboratories, LLC, effective January 8, 2026. Read the full label on DailyMed →

The FDA has 154 labels for products of this medicine (different makers and forms); uses can differ between them. Check the label that comes with your own medicine.

This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or change any medicine.

Conditions named on the label

These condition names appear word for word in the label’s “Indications and Usage” text (matched with a reviewed table). Each page lists hospitals whose own websites name the condition.

Rheumatoid arthritis

Related medical specialties

Rheumatology

Boxed warning

A boxed warning (“black box”) is the FDA’s strongest warning on a drug label, for serious or life-threatening risks.

This label has a boxed warning. Its heading: WARNING: RISK OF SERIOUS CARDIOVASCULAR AND GASTROINTESTINAL EVENTS. Read it on the full label →

141 of 154 FDA labels for this medicine have a boxed warning.

Forms and how it is given

Dosage formsTablet · Tablet, delayed release · Tablet, film coated, extended release · Tablet, film coated · Suspension
RouteOral
Prescription products224 in the FDA NDC Directory
Brand namesNaprelan, Rugby All Day Relief

What pharmacies pay (NADAC)

The National Average Drug Acquisition Cost (NADAC) is the average price U.S. retail pharmacies paid to buy one unit of a medicine (one tablet, one mL or one gram), from a monthly survey of pharmacy invoices by the Centers for Medicare & Medicaid Services (CMS). State Medicaid programs use it to pay pharmacies.

This is not the price you pay. What you pay depends on your insurance (copay or coinsurance), your pharmacy and any discounts, and pharmacies also charge for filling a prescription. Ask your pharmacist or your health plan what your price will be.

NADAC per unit for Naproxen, by strength and form
Strength and formGeneric or brandPharmacies pay
naproxen 125 mg/5 mL
suspension		 Generic $0.1220–$0.2092 per mL
3 packages, lowest to highest
naproxen 25 mg/mL
suspension		 Generic $0.1220–$0.2092 per mL
2 packages, lowest to highest
naproxen 250 mg
tablet		 Generic $0.0495 per tablet
naproxen 375 mg
tablet		 Generic $0.0577–$2.16 per tablet
14 packages, lowest to highest
naproxen 375 mg
tablet, delayed release		 Generic $2.16 per tablet
naproxen 500 mg
tablet		 Generic $0.0578–$1.95 per tablet
19 packages, lowest to highest
naproxen 500 mg
tablet, delayed release		 Generic $1.95 per tablet
naproxen sodium 275 mg
tablet		 Generic $0.1961 per tablet
naproxen sodium 275 mg
tablet, film coated		 Generic $0.1961 per tablet
naproxen sodium 500 mg
tablet, film coated, extended release		 Generic $8.78 per tablet
naproxen sodium 550 mg
tablet		 Generic $0.2154 per tablet
naproxen sodium 550 mg
tablet, film coated		 Generic $0.2154 per tablet

NADAC list of November 4, 2026; these prices took effect on October 21, 2026. Shown only where a package’s NDC code matches the NADAC list exactly, and only for that exact strength and form: nothing is averaged across strengths. Strengths and forms not listed here have no NADAC price.

Source: NADAC (National Average Drug Acquisition Cost) 2026, data.medicaid.gov (CMS) →

Companies that list this medicine

Labelers in the FDA NDC Directory: the company named on the package (maker or distributor), with the number of prescription products.

FDA approval history

  • NDA: New Drug Application: how a new (usually brand-name) medicine is approved.
  • ANDA: Abbreviated New Drug Application: how a generic version is approved.
Brand and biologic applications
ApplicationSponsorApprovedLater changes approved
NDA018965
NAPROSYN		 Atnahs Pharma UsMarch 23, 1987 22, latest November 21, 2024
2024: Labeling · 2021: Labeling · 2019: Labeling
NDA020067
EC-NAPROSYN		 Atnahs Pharma UsOctober 14, 1994 20, latest November 21, 2024
2024: Labeling · 2024: Labeling · 2021: Labeling
NDA020353
NAPRELAN		 Twi PharmsJanuary 5, 1996 24, latest November 21, 2024
2024: Labeling · 2021: Labeling · 2019: Labeling

Generic approvals (22)

Shortage status

The FDA drug shortage list does not show these products.

FDA Drug Shortages database →

Recalls

From FDA enforcement reports, matched by the product’s NDC code. A recall usually covers specific lots only: check the lot number on your package and ask your pharmacist. Do not stop a medicine on your own.

  1. April 20, 2026 · Class II · Ongoing · D-0523-2026

    Chemical contamination; presence of lead and lithium above specification

    NAPROXEN ORAL SUSPENSION, USP, 125 mg/5mL, Rx only, 16fl oz (473 mL) bottles, Distributed by: Acella Pharmaceuticals, LLC, Alpharetta, GA 30005, Made in Canada NDC 42192-619-16 — Acella Pharmaceuticals, LLC

  2. March 13, 2025 · Class II · Ongoing · D-0346-2025

    CGMP Deviations

    Naproxen Sodium Tablets, USP, 550mg, 100-count bottles, Rx Only, Manufactured by: Glenmark Pharmaceuticals Limited, Pithampur, Madhya Pradesh 454775, India, Manufactured for: Glenmark Pharmaceuticals Inc. USA, Mahwah, NJ — Glenmark Pharmaceuticals Inc., USA

  3. November 7, 2023 · Class II · Ongoing · D-0124-2024

    Labeling: Label Mix-Up-Indomethacin bottles may be labeled as Naproxen

    Naproxen Tablets, USP 250mg, 100-count bottle, Rx Only, Manufactured by: Glenmark Pharmaceuticals Ltd. Colvale-Bardez, Goa 403513, India, Manufactured for: Glenmark Pharmaceuticals Inc., USA Mahwah, NJ 07430, NDC 68462-1 — Glenmark Pharmaceuticals Inc., USA

  4. August 27, 2021 · Class II · Terminated · D-0821-2021

    CGMP Deviations

    Naproxen Sodium Tablets, USP 275 mg 100 Tablets Rx Only NDC 68462-178-01 Manufactured by: Glenmark Pharmaceuticals Inc., USA 4147 Goldmine Road Monroe, NC 28110 Manufactured for: Glenmark Pharmaceuticals Inc., USA Mahwah — Glenmark Pharmaceuticals Inc., USA

  5. August 27, 2021 · Class II · Terminated · D-0822-2021

    CGMP Deviations

    Naproxen Sodium Tablets, USP 550 mg Rx Only Manufactured by: Glenmark Pharmaceuticals Inc., USA 4147 Goldmine Road Monroe, NC 28110 Manufactured for: Glenmark Pharmaceuticals Inc., USA Mahwah, NJ 07430 a) 100 Tablets NDC — Glenmark Pharmaceuticals Inc., USA

  6. July 6, 2012 · Class II · Terminated · D-1701-2012

    Labeling: Label Mix-Up: Bottles labeled as Naproxen Tablets USP, 500 mg, 100-count may contain 90-count Pravastatin Sodium Tablets, 40 mg.

    NAPROXEN TABLETS USP, 500 mg, 100-count Tablets per bottle, Rx only, Manufactured by: Glenmark Generics Ltd., Colvale-Bardez, Goa 403513, India; Manufactured for: Glenmark Generics Inc., USA, Mahwah, NJ 07430; NDC 68462- — Glenmark Generics Inc., USA

What do the recall classes mean?

Class I: The most serious type: there is a reasonable chance that using the product will cause serious health problems or death.
Class II: Using the product may cause temporary or medically reversible health problems, or the chance of serious problems is remote.
Class III: Using the product is not likely to cause health problems (for example a labeling or packaging issue).

Official identifiers

RxCUI (RxNorm)198012, 198013, 198014, 311913, 311915, 603103, 849398, 849431, 849574, 1116320 … (+5)
SPL set ID of the quoted labelb8a51c9a-488e-4377-a041-436f6a2f8893
FDA labels (SPL)154
FDA applicationsNDA018965, NDA020067, NDA020353, 22 ANDA
Active ingredients (FDA)NAPROXEN

Sources

  1. FDA-approved label on DailyMed (National Library of Medicine) — Naprelan, Upsher-Smith Laboratories, LLC, effective January 8, 2026; via openFDA, FDA data exported October 30, 2026, retrieved October 31, 2026
  2. NDC Directory (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
  3. Drugs@FDA (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
  4. Drug recall enforcement reports (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 27, 2026, retrieved October 31, 2026
  5. Drug shortages (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026

openFDA data is provided by the FDA as is; it may be incomplete. Always rely on the label that comes with your medicine. FDA Enforcement Report search →

Report an error → · Information for medicine makers